New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

01/25/2010

Trade Name:

Sandostatin and Sandostatin LAR

Generic Name or Proper Name (*):

octreotide

Indications Studied:

Weight loss due to hypothalamic obesity from cranial insult

Label Changes Summary:

* Post-marketing reports of hypoxia, necrotizing enterocolitis, and death in children added to Pediatric Use. The relationship of these events to octreotide has not been established. * Pediatric Use subsection of Sandostatin labeling harmonized with Sandostatin LAR labeling